EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task.
Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due. A large component of that strategy centres on the actual data submission – how to submit a large number of medical device records to EUDAMED in an efficient, scalable and cost‑effective process.
Today, there are really two main methods for submitting data via M2M to regulatory agencies – using a GDSN data pool or opting for a direct connection to regulatory databases via an approved Third‑Party Submission system. Read on for a brief Q&A with Bruck Assefa, Director of Product Management, regarding the two approaches when it comes to EUDAMED.
How are medical device companies using GDSN?
There are several medical device companies that already use GDSN to provide commercial and supply chain data to GPOs, distributors and hospitals. Some of these companies also leveraged their work with GDSN to submit UDI data to the FDA’s GUDID as it provided them with a single channel for publishing commercial and regulatory product data. We’re now seeing some companies ask whether they can take the same approach with GDSN for submitting data to EUDAMED.
What are the advantages and disadvantages of using GDSN for data submission to EUDAMED?
As it currently stands, GDSN is not quite ready to support the full data submission requirements for EUDAMED. It doesn’t mean that it will not be in the future as GS1 has already started rolling out healthcare attributes required for EUDAMED. However, it is important to consider the data model complexity and relationship EUDAMED brings (Basic UDI, UDI-DI, Legacy Devices, Container Packs, etc.) and the appropriate mapping that needs to be done for the acknowledgement messages. How all of this will be handled via GDSN is not yet clear.
Notwithstanding, it’s also important to understand the current advantages and disadvantages of using GDSN for purposes of regulatory (UDI) data submission.
Please note that Innovit will support both UDI regulatory submissions via GDSN and direct connection methods, the most appropriate approach depends on each med device companies’ operating model, internal regulatory compliance guidelines and IT landscape.
- Message gateway & single outbound channel – if already connected to a GDSN data pool, it means commercial data to trading partners and regulatory data to regulatory agencies can all go through a single channel via the same message gateway.
- More standardised data model mapping – attributes and data types – GDSN offers a standards-based attribute definition and GS1 XML schema. This means internal attributes only need to be mapped once into the GDSN attribute format regardless of whether the data needs to be sent to trading partners or regulatory agencies.
- Simpler external IT integration model – Using GDSN means manufacturers only need to build interfaces to bring their source data into an application that can integrate to their chosen GDSN data pool provider. The transformation and submission of regulatory data to the relevant regulatory agencies will be done by the data pool and is abstracted from the manufacturer.
While it’s true that using GDSN does seem to be more efficient, using one channel and one messaging gateway for all master data exchange does present some clear disadvantages.
- Data mapping & transformation – There are at least two levels of mapping that need to happen to a customer’s data before it reaches GUDID/EUDAMED. First, it needs to be transformed into a GDSN format, then it needs to be re-transformed again to the regulatory agency’s format. In essence, it really is two different languages. What users see in the application when maintaining data is mapped to a GDSN nomenclature but what ultimately gets submitted to GUDID/EUDAMED is based on the regulators’ own terminology and data dictionary. This is especially problematic when users call the FDA’s Helpdesk or EC’s support team to resolve data submission issues.
- Time requirements & delays – GDSN has its own internal processes for attribute review and approval before it gets incorporated in the Global Data Dictionary (GDD). This means more lead time is required before a new attribute is introduced by a regulatory agency (such as EUDAMED) and when it can be incorporated into GDSN – this may introduce additional risks that medical device manufacturers can’t afford to bear.
- More complex data models – EUDAMED is far more complex than the GUDID data model. It requires more product data attributes and relationships between different entities (Basic UDI, UDI-DI, Legacy Devices, Market Info and Container Packs). It is still unclear how these relationships will be supported in GDSN. How errors and acknowledgements are going to be mapped into standard GDSN confirmation messages is also not understood.
- Cost of System Validation – GDSN generally introduces 4 maintenance releases per year with one of them begin a major release. While these changes may not be related to regulatory data requirements, updating their GDSN solution with such frequency may mean higher system validation costs for manufacturers.
What are you seeing in the market?
At Innovit, we definitely see a trend developing where companies are moving toward direct submission. In fact, we’ve even seen some GDSN data pool providers build their own direct-to-EUDAMED connector (not via GDSN). And some GDSN data pool providers have even started partnering with vendors who plan to build a direct EUDAMED connection as an alternative to using their GDSN platform. This is proving to be the safest approach that a lot of manufacturers are taking given the pressure of upcoming deadlines and the uncertainty around how GDSN will fully support the EUDAMED data submission requirements.